This online course describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices that are required to meet FDA’s regulations. It identifies ways to organize policies and procedures, and plans FDA expects a manufacturing company to establish. This course draws on current industry good practice. Though it also draws on FDA medical device guidance, this course is not intended to describe an approach to developing software that subsequently becomes part of a medical device. This is the second course in a series of four courses. Before taking this course, you should have successfully completed Requirements for Computerized Systems Validation and Compliance.
Your company needs to have a specific approach to the validation and compliance of computerized systems. This course identifies ways to organize policies and procedures, and plans FDA would expect a regulated firm to establish to meet requirements. It further outlines an acceptable approach to defining an adequate validation strategy, discusses the documentation of the associated validation activities, and identifies what operation, maintenance, and control procedures the regulated healthcare customer or organization contracting a supplier to provide a product. The term is not intended to apply only to individuals who use the computerized system. Later courses in the series will address the inspection of computerized systems.
After more than four years of rework, the Good Automated Manufacturing Practices (GAMP) 4 Guide was reissued as GAMP 5 in March 2008. The GAMP Guide has been significantly updated to align with the concepts and terminology of recent regulatory and industry developments. GAMP 5 concepts, which focus on risk, will also be addressed in this course. This course addresses the following:
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA CDRH and CBER January 2002
- Guidance for Industry — Part 11; Electronic Records; Electronic Signatures — Scope and Application, Final Rule, August 2003
- GAMP 5: GAMP Guide for Validation of Automated Systems (A Risk-Based Approach to Compliant GxP Computerized Systems), March 2008
- Guidance for Industry — Process Validation: General Principles and Practices, January, 2011, rev. 1
- Guide to Inspection of Computerized Systems in Drug Processing, FDA ORA February 1983
- Glossary of Computerized System and Software Development Terminology, FDA ORA August 1995
Take Back to Your Job:
After completing this course, you will be able to:
- Identify the type of framework that is suitable for computerized systems validation and compliance.
- Recognize planning and reporting requirements.
- recognize how a validation strategy is selected and the activities that are required to ensure ongoing compliance.
Attendance Suggested For:
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
- Computer system vendors or consultants, engineering contractors, and validation service companies.